ObesityNCT01371370
Low-intensity Resistance Exercise and Diet on Arterial Function and Blood Pressure
A study testing Resistance exercise training, Hypocaloric diet and Resistance exercise training & diet in people with Obesity and Pre-hypertension, run by Florida State University at 1 site in United States.
Trial summary
Obesity is a major risk factor for premature arterial abnormalities including high blood pressure and increased stiffness. Previous studies have shown that weight loss via lifestyle modifications is associated with a decrease in large artery (aorta) stiffness. Read more about this study
- Who is it for?
- Ages 40 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Pre-hypertension, Hypertension
- What is being tested?
- Resistance exercise training, Hypocaloric diet and Resistance exercise training & diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Jun 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female
- 40 to 65 years of age
- Body mass index of 27-39.9
- Sedentary or low active (less than 2 hr per wk)
Who cannot join
- Younger than 40 or older than 65 years of age
- Body mass index lower than 27, or 40 or higher
- Physically active or competitively active
- Smoker
- Systolic blood pressure higher than 140 mmHg
- Use of hormone replacement therapy of less than 1 yr
Show all 9Show fewer
- Use of calcium channel blocker or beta blockers
- Type 1 diabetes
- Uncontrolled type 2 diabetes
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32306
About this study
Official title: Effects of Low-intensity Resistance Exercise Training and Diet on Central Hemodynamics and Arterial Stiffness in Obese Middle-aged Women With High Blood Pressure
- Obesity is a major risk factor for premature arterial abnormalities including high blood pressure and increased stiffness. Previous studies have shown that weight loss via lifestyle modifications is associated with a decrease in large artery (aorta) stiffness. However, along with decreases in fat mass, hypocaloric diet reduces muscle mass. Low-intensity resistance exercise training (LIRET) results in similar increases in muscle mass and strength than those observed after high-intensity resistance exercise.
- The investigators hypothesis is that weight loss via diet combined with LIRET would additively reduce arterial stiffness and blood pressure (BP) in obese women. The investigators also hypothesize that the improved arterial function with weight loss would be associated with beneficial changes in the main mechanisms involved in BP regulation.
Read the detailed description
The purpose of the study is to examine the effects of 12 weeks of low-intensity resistance exercise training (LIRET) and diet on arterial function, autonomic function, and body composition in obese women with high blood pressure (BP). Specific aims of the study are to:
- To evaluate the extent to which diet and LIRET will improve body composition assessed by changes in fat mass and lean mass using dual-energy x-ray absorptiometry and waist circumference.
- To investigate that combined diet and LIRET are more efficacious than either treatment alone in ameliorating cardiovascular disease risk factors by assessing arterial stiffness (aortic, systemic, and leg), aortic BP and wave reflection, and autonomic function (heart rate variability, vascular sympathetic activity [low-frequency power of systolic BP variability], and baroreflex sensitivity). Circulating levels of adipocytokines (adiponectin and leptin) and endothelial-derived vasodilators (NO metabolites [NOx] and prostacyclin) and vasoconstrictors (endothelin-1 and prostaglandin F2α) will be assessed as secondary outcome variables.
- Conditions
- Obesity, Pre-hypertension, Hypertension
- Being tested
- Resistance exercise training, Hypocaloric diet, Resistance exercise training & diet
- Keywords
- low intensity resistance exercise training, hypocaloric diet, prehypertension, hypertension, obesity, arterial function, arterial stiffness, pulse wave velocity, autonomic function, endothelial function, adipocytokines
- Medical subject headings
- Obesity, Prehypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance exercise trainingOther
The low intensity resistance exercise training intervention consists of lower-body resistance exercise (machines) 3 times per wk for 12 wk. Two sets the first 2 wk and 3 sets the rest of the intervention, at 40% of the estimated 1 repetition maximum, for 17 to 23 repetitions, with 1 minute of rest in between sets.
Hypocaloric dietOther
The hypocaloric diet intervention consists of 12 wk of the standard Nutrisystem foods plan complemented by fresh produce and dairy. Subjects consume breakfast, lunch, dinner, and one (women) or two (men) snacks per day.
Resistance exercise training & dietOther
Combination of low intensity resistance exercise training and hypocaloric diet
| Study group | Role | What they receive |
|---|---|---|
| Resistance exercise training | Experimental | Lower-body exercises 3 times per wk for 12 wk Receives: Other: Resistance exercise training |
| Hypocaloric diet | Experimental | This arm involves 12 wk of the standard Nutrisystem foods plan complemented by fresh produce and dairy. Subjects consume breakfast, lunch, dinner, and one (women) or two (men) snacks per day. Receives: Other: Hypocaloric diet |
| Resistance exercise training & diet | Experimental | Lower-body exercise training and diet Receives: Other: Resistance exercise training & diet |
| Control | No intervention | This arm involves not making any change to the subject's lifestyle at the moment of the start of the intervention and for 12 wk. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Non-invasive measures of brachial and aortic blood pressure
Measured: 12 weeks
Secondary outcomes (5)
Autonomic Function
Heart rate variability, vascular sympathetic activity [low-frequency power of systolic BP variability], and spontaneous baroreflex sensitivity will be assessed from electrocardiogram and beat-by-beat digital blood pressure
Measured: 12 weeks
Endothelial Function
By measuring circulating levels of adipocytokines (adiponectin and leptin) and endothelial-derived vasodilators (NO metabolites [NOx] and prostacyclin) and vasoconstrictors (endothelin-1 and prostaglandin F2α)
Measured: 12 weeks
Body Composition
By measuring fat mass and lean soft tissue mass from dual-energy x-ray absorptiometry and waist circumference
Measured: 12 weeks
Arterial Stiffness
Using pulse wave velocity of the aorta, systemic, and legs
Measured: 12 weeks
Pressure Wave Reflection
Using the augmentation index from radial tonometry
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- Nutrisystem, Inc.
- Responsible party
- Principal investigator, Arturo Figueroa, Florida State University
- Investigators
- Arturo Figueroa, M.D., Ph.D., Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371370
- Sponsor's protocol ID
- 2011.5485
- Status last verified
- Aug 2014
- First submitted
- 9 Jun 2011
- Last updated
- 5 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Figueroa A, Vicil F, Sanchez-Gonzalez MA, Wong A, Ormsbee MJ, Hooshmand S, Daggy B. Effects of diet and/or low-intensity resistance exercise training on arterial stiffness, adiposity, and lean mass in obese postmenopausal women. Am J Hypertens. 2013 Mar;26(3):416-23. doi: 10.1093/ajh/hps050. Epub 2013 Jan 7.
PubMed 23382493
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low-intensity Resistance Exercise Training and Diet on Central Hemodynamics and Arterial Stiffness in Obese Middle-aged Women With High Blood Pressure
- ClinicalTrials.gov ID
- NCT01371370
- Acronym / sponsor ID
- 2011.5485
- Conditions
- Obesity, Pre-hypertension, Hypertension
- Keywords
- low intensity resistance exercise training, hypocaloric diet, prehypertension, hypertension, obesity, arterial function, arterial stiffness, pulse wave velocity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- Nutrisystem, Inc.
- Study start
- Dec 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 10 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Obesity is a major risk factor for premature arterial abnormalities including high blood pressure and increased stiffness. Previous studies have shown that weight loss via lifestyle modifications is associated with a decrease in large artery (aorta) stiffness. However, along with decreases in fat mass, hypocaloric diet reduces muscle mass. Low-intensity resistance exercise training (LIRET) results in similar increases in muscle mass and strength than those observed after high-intensity resistance exercise.
- The investigators hypothesis is that weight loss via diet combined with LIRET would additively reduce arterial stiffness and blood pressure (BP) in obese women. The investigators also hypothesize that the improved arterial function with weight loss would be associated with beneficial changes in the main mechanisms involved in BP regulation.
Detailed description
The purpose of the study is to examine the effects of 12 weeks of low-intensity resistance exercise training (LIRET) and diet on arterial function, autonomic function, and body composition in obese women with high blood pressure (BP). Specific aims of the study are to:
- To evaluate the extent to which diet and LIRET will improve body composition assessed by changes in fat mass and lean mass using dual-energy x-ray absorptiometry and waist circumference.
- To investigate that combined diet and LIRET are more efficacious than either treatment alone in ameliorating cardiovascular disease risk factors by assessing arterial stiffness (aortic, systemic, and leg), aortic BP and wave reflection, and autonomic function (heart rate variability, vascular sympathetic activity [low-frequency power of systolic BP variability], and baroreflex sensitivity). Circulating levels of adipocytokines (adiponectin and leptin) and endothelial-derived vasodilators (NO metabolites [NOx] and prostacyclin) and vasoconstrictors (endothelin-1 and prostaglandin F2α) will be assessed as secondary outcome variables.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Resistance exercise training | Experimental | Other: Resistance exercise trainingLower-body exercises 3 times per wk for 12 wk |
| Hypocaloric diet | Experimental | Other: Hypocaloric dietThis arm involves 12 wk of the standard Nutrisystem foods plan complemented by fresh produce and dairy. Subjects consume breakfast, lunch, dinner, and one (women) or two (men) snacks per day. |
| Resistance exercise training & diet | Experimental | Other: Resistance exercise training & dietLower-body exercise training and diet |
| Control | No intervention | –This arm involves not making any change to the subject's lifestyle at the moment of the start of the intervention and for 12 wk. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female
- 40 to 65 years of age
- Body mass index of 27-39.9
- Sedentary or low active (less than 2 hr per wk)
Key exclusion criteria (9 listed)
- Younger than 40 or older than 65 years of age
- Body mass index lower than 27, or 40 or higher
- Physically active or competitively active
- Smoker
- Systolic blood pressure higher than 140 mmHg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance exercise trainingThe low intensity resistance exercise training intervention consists of lower-body resistance exercise (machines) 3 times per wk for 12 wk. Two sets the first 2 wk and 3 sets the rest of the intervention, at 40% of the estimated 1 repetition maximum, for 17 to 23 repetitions, with 1 minute of rest in between sets. | Other | Resistance exercise training |
| Hypocaloric dietThe hypocaloric diet intervention consists of 12 wk of the standard Nutrisystem foods plan complemented by fresh produce and dairy. Subjects consume breakfast, lunch, dinner, and one (women) or two (men) snacks per day. | Other | Hypocaloric diet |
| Resistance exercise training & dietCombination of low intensity resistance exercise training and hypocaloric diet | Other | Resistance exercise training & diet |
Primary outcome
Blood pressure
Time frame: 12 weeks
Non-invasive measures of brachial and aortic blood pressure
5 secondary outcomes
Autonomic Function
Time frame: 12 weeks
Endothelial Function
Time frame: 12 weeks
Body Composition
Time frame: 12 weeks
Arterial Stiffness
Time frame: 12 weeks
Pressure Wave Reflection
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
- Derived from this study: PubMed 23382493Figueroa A, Vicil F, Sanchez-Gonzalez MA, Wong A, Ormsbee MJ, Hooshmand S, Daggy B. Effects of diet and/or low-intensity resistance exercise training on arterial stiffness, adiposity, and lean mass in obese postmenopausal women. Am J Hypertens. 2013 Mar;26(3):416-23. doi: 10.1093/ajh/hps050. Epub 2013 Jan 7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arturo Figueroa, M.D., Ph.D. principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance exercise training, Hypocaloric diet and Resistance exercise training & diet in people with Obesity and Pre-hypertension, run by Florida State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01371370, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2014.